药品注册申请号:050169
申请类型:NDA (新药申请)
申请人:MONARCH PHARMS
申请人全名:MONARCH PHARMACEUTICALS LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 CORTISPORIN HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SUSPENSION/DROPS;OPHTHALMIC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML No No None 1964/12/18 Approved Prior to Jan 1, 1982 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2003/11/25 SUPPL-46(补充) Approval Labeling STANDARD
1999/04/19 SUPPL-45(补充) Approval Manufacturing (CMC)
1995/06/13 SUPPL-44(补充) Approval Manufacturing (CMC)
1994/05/10 SUPPL-9(补充) Approval Labeling
1985/12/13 SUPPL-8(补充) Approval Manufacturing (CMC)
1984/08/21 SUPPL-7(补充) Approval Manufacturing (CMC)
1984/02/28 SUPPL-6(补充) Approval Manufacturing (CMC)
1983/03/30 SUPPL-1(补充) Approval Labeling
1982/09/13 SUPPL-42(补充) Approval Manufacturing (CMC)
1982/03/26 SUPPL-41(补充) Approval Manufacturing (CMC)
1982/01/26 SUPPL-40(补充) Approval Manufacturing (CMC)
1981/10/20 SUPPL-37(补充) Approval Manufacturing (CMC)
1981/09/15 SUPPL-36(补充) Approval Manufacturing (CMC)
1981/01/16 SUPPL-34(补充) Approval Efficacy
1980/12/01 SUPPL-35(补充) Approval Labeling
1972/11/20 SUPPL-31(补充) Approval Labeling
1972/07/06 SUPPL-30(补充) Approval Labeling
1972/06/21 SUPPL-28(补充) Approval Labeling
1971/05/11 SUPPL-25(补充) Approval Manufacturing (CMC)
1970/12/18 SUPPL-24(补充) Approval Labeling
1970/10/09 SUPPL-23(补充) Approval Labeling
1970/07/27 SUPPL-22(补充) Approval Labeling
1969/03/25 SUPPL-19(补充) Approval Manufacturing (CMC)
1969/03/24 SUPPL-17(补充) Approval Manufacturing (CMC)
1969/03/17 SUPPL-20(补充) Approval Manufacturing (CMC)
1967/07/13 SUPPL-16(补充) Approval Labeling
1967/04/20 SUPPL-15(补充) Approval Labeling
1967/04/10 SUPPL-14(补充) Approval Labeling
1967/04/04 SUPPL-13(补充) Approval Labeling
1966/10/19 SUPPL-12(补充) Approval Labeling
1966/09/13 SUPPL-10(补充) Approval Labeling
1966/05/05 SUPPL-3(补充) Approval Labeling
1965/09/30 SUPPL-2(补充) Approval Labeling
1964/12/18 ORIG-1(原始申请) Approval UNKNOWN
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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